About Cellares
Accelerating access to life-saving cell therapies
Key Highlights
- Developed the CEll Shuttle platform for high-throughput production
- Partners with industry leaders like Kite and Bristol Myers Squibb
- Over $355M raised in Series B funding
- Located in South San Francisco, CA with 201-500 employees
Cellares is a pioneering provider of cell therapy manufacturing services, headquartered in South San Francisco, CA. With over $355M in funding, Cellares has developed the CEll Shuttle platform, an automated system capable of producing 16 batches of CAR T-cell therapies simultaneously, reducing batch...
🎁 Benefits
Cellares offers a flexible vacation policy, comprehensive healthcare, 401k with company match, parental leave, catered onsite meals, and premium techn...
🌟 Culture
Cellares fosters a culture focused on efficiency and scalability in cell therapy manufacturing. The company prioritizes innovation and collaboration, ...
Other Technical Roles • Senior
Overview
Cellares is seeking a Senior Director of IDMO Site Quality to lead the Quality organization in a state-of-the-art cell therapy manufacturing facility. This role requires strategic leadership and collaboration across various functions to ensure compliance with cGMP operations.
Job Description
Who you are
You are a highly motivated leader with extensive experience in quality management within the biopharmaceutical or cell therapy sectors. You have a proven track record of overseeing cGMP operations and ensuring regulatory compliance, demonstrating your ability to navigate complex quality systems and processes. Your leadership style fosters effective communication and collaboration across multidisciplinary teams, allowing you to drive alignment with customer needs and business strategies.
You thrive in fast-paced, mission-driven environments and are prepared to tackle a broad selection of challenges as the company grows. Your ability to interface with all levels of the organization, including Operations, MS&T, Process/Analytical Development, Supply Chain, and Engineering, showcases your versatility and adaptability in a dynamic setting. You possess strong problem-solving skills and a commitment to maintaining the highest quality standards in manufacturing operations.
What you'll do
As the Senior Director of IDMO Site Quality, you will play a critical role in the launch and ramp-up of a multi-product cell therapy manufacturing facility. You will lead the Quality organization, overseeing both Quality Assurance and Quality Control functions to ensure the safe and compliant production of cell therapy products. Your strategic leadership will be essential in expanding the site Quality Management Systems (QMS) and ensuring adherence to regulatory requirements.
You will partner with various functions to drive robust production, testing, and release of products to patients. This includes collaborating with Operations, MS&T, and other cross-functional groups to ensure that all processes align with cGMP standards. Your role will require you to provide guidance and support to your team, fostering a culture of quality and compliance throughout the organization.
In addition to overseeing daily operations, you will be responsible for developing and implementing quality strategies that align with the company's business objectives. You will lead initiatives to enhance the quality systems and processes, ensuring that they are effective and efficient in meeting regulatory expectations. Your ability to communicate effectively with stakeholders at all levels will be crucial in driving quality initiatives and ensuring that the organization meets its quality goals.
What we offer
Cellares offers a collaborative and innovative work environment where you can make a significant impact on the future of cell therapy manufacturing. You will have the opportunity to work with a talented team dedicated to advancing the field of cell therapy and improving patient outcomes. We encourage you to apply even if your experience doesn't match every requirement, as we value diverse perspectives and backgrounds.
Join us in our mission to revolutionize cell therapy manufacturing and contribute to the development of life-saving treatments for patients. We are committed to providing our employees with the resources and support they need to succeed in their roles and grow within the organization.
Interested in this role?
Apply now or save it for later. Get alerts for similar jobs at Cellares.
Similar Jobs You Might Like
Based on your interests and this role
Director Of Site Quality
Hims & Hers is hiring a Director of Site Quality to develop and maintain quality systems for their compounding facility. You'll ensure product quality and efficacy while fostering a quality culture. This role requires significant experience in quality assurance and control.
Director Of Site Quality
Hims & Hers is hiring a Director of Site Quality to develop and maintain quality systems for their compounding facility. You'll ensure product quality and integrity while fostering a quality culture. This role requires significant experience in quality assurance and control.
Quality Manager
BillionToOne is seeking a Director of Quality to lead operational quality initiatives in their CLIA-certified laboratory. You'll drive continuous improvement efforts and work cross-functionally with various teams. This role requires strong leadership and a commitment to enhancing quality systems.
Program Manager
Hims & Hers is hiring a Director of Quality Program Management to lead quality initiatives and manage a team of Quality Program Managers. This role focuses on supporting the Global Head of Quality across compounding programs and requires strong project management skills.
Operations Manager
Constellation is hiring a Director of Site Services to oversee all site operations, including IT, Security & Safety, and Catering. You'll lead a growing team and define the strategic direction for the research center in Berkeley, CA.